Status:
WITHDRAWN
Evaluation Cardiac Function With Echo and BNP in Obstetrical Patients With/Without Cardiac Disease
Lead Sponsor:
State University of New York - Upstate Medical University
Collaborating Sponsors:
Crouse Hospital
Central New York Community Foundation, Inc.
Conditions:
Pregnancy
Heart Diseases
Eligibility:
FEMALE
18-50 years
Brief Summary
Maternal cardiac disease complicates approximately 2 percent of pregnancies and is the leading cause of non-obstetrical maternal death. Evaluating cardiac function and dysfunction is a complex process...
Detailed Description
The incidence of cardiac disease during pregnancy is about 2 percent, and is the leading cause of non-obstetrical maternal mortality (1). Women with known cardiac disease and suspected cardiac dysfunc...
Eligibility Criteria
Inclusion
- Potential subjects for the cardiac disease in pregnancy cohort:
- At least 18 years of age
- Cardiac disease as per Clark's Maternal Mortality Associated with Pregnancy: Group 1 (mortality less than 1%) atrial septal defect, ventricular septal defect, patent ductus arteriosus, pulmonic or tricuspid valve disease, corrected tetrology of Fallot, bioprosthetic valve, mitral stenosis with NYHA class I and II functional status Group 2 (mortality 5-15%) mitral stenosis with NYHA class III and IV functional status, aortic stenosis, coarctation of aorta without valvular involvement, uncorrected tetrology of Fallot, previous myocardial infarction, Marfan syndrome with normal aorta, mitral stenosis with atrial fibrillation, artificial valve Group 3 (mortality 25-50%) pulmonary hypertension, coarctation of aorta with valvular involvement, Marfan syndrome with aortic involvement (7)
- Other significant cardiac disease not listed above
- Other medical disorders, such as diabetes mellitus, chronic hypertension, asthma, other endocrine disorders, et cetera, will be acceptable
- Diagnosis of a least a single intrauterine pregnancy, multiple gestation acceptable
- Potential subjects for pregnancy without cardiac disease cohort:
- At least 18 years of age
- Absence of significant cardiac disease, minor cardiac disorders such as mitral valve prolapse without arrythmia
- Other medical disorders, not directly related to cardiac disease, such as diabetes mellitus, chronic hypertension, asthma, other endocrine disorders et cetera, will be acceptable
- Diagnosis of at least a single intrauterine pregnancy, multiple gestation acceptable
Exclusion
- Less than 18 years of age
- Non-viable pregnancy such as a threatened spontaneous miscarriage, or ectopic pregnancy
- Planned termination of pregnancy, either elective or medically indicated based on history
- Inability to complete informed consent process or participate in the study protocol
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00759733
Start Date
July 1 2008
End Date
July 1 2008
Last Update
October 13 2021
Active Locations (2)
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1
Regional Perinatal Center
Syracuse, New York, United States, 13202
2
Cardiology Associates Central New York Physician Office Building
Syracuse, New York, United States, 13210